Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty
Not Applicable
Completed
- Conditions
- Patients Suitable for THA
- Interventions
- Device: ASR hip prosthesisDevice: ReCap hip prosthesis
- Registration Number
- NCT00249054
- Lead Sponsor
- Frederiksberg University Hospital
- Brief Summary
This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by:
Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.
Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range of motion. Scanning: DEXA and MRI
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
ASA I-II,DEXA-scanning:
- lower limit for a 55 years old women,
- MRI normal
- vitality in caput
- willing to return for follow-up evaluations.
Exclusion Criteria
- collum femoris < 2 cm
- large cysts in caput (> 1 cm)
- mismatch between caput and acetabulum
- caput necrosis
- treatment with medicine which affects bone metabolism
- impaired kidney function.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASR hip prosthesis ASR hip prosthesis DuPuy ASR hip prosthesis ASR hip prosthesis ReCap hip prosthesis DuPuy ASR hip prosthesis ReCap hip prosthesis ReCap hip prosthesis Biomet ReCap hip prosthesis
- Primary Outcome Measures
Name Time Method Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up. 10 year follow up follow with intervals of 1 to 3 years for determination of function and prosthesis survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Frederiksberg University Hospital
🇩🇰Frederiksberg, Copenhagen, Denmark